Jean-Michel Cardot and E. Beyssac
During the past three years,
cleaning or cleaningvalidation
problems ranked in
the top four of the 483s and
warning letters issued by the FDA (1,
2), reflecting the agency’s emphasis on
cleaning. The main points mentioned
are a lack of documented procedures,
inadequate training of workers, and
insufficient validation of analytical
and/or cleaning methods.
Tidak ada komentar:
Posting Komentar